JP2023526943A - Medical devices with photosensitizers and related methods - Google Patents

Abstract

A medical device can include a body and a photosensitizer integrated with the body. Medical devices can passively resist bacterial colonization under ambient light. The medical device also kills bacteria by releasing reactive oxidative species (ROS) in response to administration of light doses ranging from 0.5 J/cm to 320 J/cm for 1 second to 1 hour. It can actively resist colonization. The body may be formed of a base resin. A photosensitizer may be mixed with the base resin. Photosensitizers can be absorbed into the base resin. A medical device may include a coating disposed on a surface of the body. A photosensitizer may be disposed within the coating. The medical device may include a catheter adapter and a catheter extending distally from the catheter adapter. The catheter can be coextruded with the photosensitizer and another material.

Description

The present disclosure relates generally to medical devices and related methods that promote decontamination and antimicrobial resistance.

Various types of photosensitizers exist, each with a specific excitation wavelength. During photoactivation of the photosensitizer, the excitable electrons are promoted to a higher energy level and the photosensitizer reaches a first excited singlet state. The first excited singlet state decays to a lower energy level by emitting fluorescence or, alternatively, by a process of intersystem crossing to a state called a triplet. The triplet state is long-lived, a feature that allows it to react with triplet oxygen molecules and other biomolecules and to emit phosphorescence. When the triplet state photosensitizer transfers energy to triplet oxygen, a highly reactive species called singlet oxygen is generated. Both triplet-state photosensitizers and singlet oxygen are labile molecules, and thus they are found in living tissue after photosensitizer irradiation, polyunsaturated lipids, nucleic acids, and Causes damage to proteins.

A direct reaction between a triplet state photosensitizer and a biomolecule is called a Type 1 reaction, and this process leads to photosensitizer branching. The generation of singlet oxygen by the triplet state photosensitizer is called a type 2 reaction and regenerates the ground state photosensitizer. Both type 1 and type 2 reactions can damage cells, but more severe damage is induced by type 2 reactions than by type 1 reactions.

Catheters are traditionally used to infuse fluids such as saline, various medications, and/or total parenteral nutrition into a patient. Such catheters may also be used to withdraw blood from a patient and/or monitor various parameters of the patient's vasculature. An introducer needle, which may include a sharp distal tip, may be used to introduce the catheter into the patient. The catheter may comprise an over-the-needle peripheral intravenous (IV) catheter mounted over an introducer needle. The inner surface of the catheter can be in intimate engagement with the outer surface of the introducer needle to prevent dislodgement of the catheter and facilitate insertion of the catheter into the blood vessel. The sharp distal tip of the introducer needle extends beyond the distal tip of the catheter to permit insertion of the catheter through the patient's skin and into the blood vessel at a shallow angle.

To confirm proper placement of the needle and catheter within the vessel, the clinician may confirm the presence of "flashback" blood within the flashback chamber associated with the catheter and needle assembly. Once proper placement is confirmed, the clinician may then apply pressure to the vessel to occlude it, thereby reducing further blood flow through the introducer needle and catheter. The clinician can then withdraw the needle from the catheter to allow continued access to the vessel through the catheter.

Catheters are susceptible to bacteria that can infect and harm the patient. Similarly, ultrasound equipment, dressings, pumps, and other medical equipment and other vascular access devices in close proximity to the patient are susceptible to bacteria that can infect and harm the patient. A need exists for materials that can enhance the antimicrobial resistance of medical devices.

The subject matter claimed in this disclosure is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one exemplary technology area in which some implementations described in this disclosure may be practiced.
SUMMARY The present disclosure relates generally to medical devices and related methods that promote decontamination and antimicrobial resistance. In some embodiments, a medical device can include a body and a photosensitizer integrated with the body. In some embodiments, the photosensitizer can include methylene blue, new methylene blue, nile blue, rose bengal, toluidine blue O, crystal violet, or another suitable photosensitizer. In some embodiments, the body can include multiple photosensitizers integrated with the body.

Photosensitizers can be integrated into the body in a variety of ways. For example, the body can be formed of a base resin, and the photosensitizer can be mixed with the base resin. In some embodiments, the base resin can include polyphenylsulfone, polyurethane, or silicone. In some embodiments, the concentration of photosensitizer within the base resin can be between 0.05% and 5%.

As another example, a medical device may include a coating disposed on a surface of the body, and the photosensitizer may be disposed within the coating. In some embodiments, the concentration of photosensitizer in the coating can be between 0.05% and 5%. As yet another example, a medical device may include a catheter adapter and a catheter extending distally from the catheter adapter. In these embodiments, the catheter can be coextruded with the photosensitizer and another material. As a further example, the body can be formed by a base resin, and the photosensitizer is absorbed into the base resin.

In some embodiments, a medical device may include a needle-free connector or cap. In some embodiments, a medical device may include an ultrasound transducer. In some embodiments, the medical device may comprise a dressing, surgical mesh, pump, or another suitable medical device.

In some embodiments, a method of disinfecting a medical device can include providing a medical device. In some embodiments, the method can include administering a dose of light ranging between 0.5 J/cm ² and 320 J/cm ² to a photosensitizer integrated with the body. In some embodiments, the dose of light can be administered for between 1 second and 1 hour.

In some embodiments, the method can include integrating the photosensitizer with the body of the medical device. In some embodiments, integrating the photosensitizer with the body of the medical device can include mixing the photosensitizer with the base resin. In some embodiments, integrating the photosensitizer with the body of the medical device can include applying a coating to the surface of the medical device. In some embodiments, the medical device can include a catheter adapter and a catheter, and integrating the photosensitizer with the body of the medical device coextrudes the catheter with the photosensitizer and another material. can include In some embodiments, integrating the photosensitizer with the body of the medical device can include absorbing the photosensitizer into the base resin.

It is to be understood that both the foregoing general description and the following detailed description are examples and illustrations, and are not limiting of the disclosure as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. Also, embodiments may be combined or other embodiments may be utilized and, unless so claimed, structural changes depart from the scope of some embodiments of the present disclosure. It should be understood that it can be done without Therefore, the following detailed description should not be taken in a limiting sense.

Exemplary embodiments are described and explained with additional specificity and detail through the use of the accompanying drawings.

1 is a top perspective view of an exemplary medical device, according to some embodiments; FIG. 1B is a cross-sectional view of the medical device of FIG. 1A showing exemplary coatings, according to some embodiments; FIG. FIG. 10 is a top perspective view of another exemplary medical device, according to some embodiments; FIG. 10 is a top perspective view of another exemplary medical device, according to some embodiments; FIG. 10 is a top perspective view of another exemplary medical device, according to some embodiments; FIG. 10 is a top perspective view of another exemplary medical device, according to some embodiments; 2B is an enlarged top perspective view of the medical device of FIG. 2A, according to some embodiments; FIG. 1 is a schematic diagram of an exemplary chamber for providing light dosage to a medical device, according to some embodiments; FIG.

DETAILED DESCRIPTION Referring now to FIG. 1A, a medical device 10 is shown. For example, as shown in FIG. 1, medical device 10 may include an ultrasound transducer. In other embodiments, medical device 10 may include catheters, catheter adapters, connectors, caps, ultrasound transducers, dressings, surgical meshes, pumps, or other suitable medical devices for contacting or approximating a patient.

In some embodiments, medical device 10 can include body 12 and a photosensitizer integrated with body 12 . In some embodiments, body 12 may include any portion of medical device 10 that contacts or is near the patient. In some embodiments, medical device 10 may include an ultrasonic transducer and body 12 may include a distal end 14 of the ultrasonic transducer. In some embodiments, the photosensitizer can include methylene blue, new methylene blue, nile blue, rose bengal, toluidine blue O, crystal violet, or another suitable photosensitizer.

In some embodiments, photosensitizers can be integrated with body 12 in a variety of ways. In some embodiments, body 12 may be formed by a base resin and the photosensitizer may be mixed with the base resin. In some embodiments, the base resin may comprise polyphenylsulfone, polyurethane, silicone, or another suitable base resin. In some embodiments, the concentration of photosensitizer within the base resin can be between 0.05% and 5%.

In some embodiments, body 12 may be formed by a base resin and the photosensitizer may be absorbed into the base resin. In some embodiments, imbibing can include dissolving the photosensitizer in methyl ethyl ketone (MEK), tetrahydrofuran (THF), or another suitable solvent to form a solution. In some embodiments, imbibing can include exposing body 12 to a solution, such that body 12 imbibes the solution and swells. In some embodiments, body 12 can be coextruded with a photosensitizer and another material using a die.

In some embodiments, body 12 may actively resist bacterial colonization by releasing reactive oxidizing species (ROS) in response to the amount of light. In some embodiments, a light dose that can range between 0.5 J/cm ² and 320 J/cm ² can be administered to a photosensitizer integrated with body 12 . In some embodiments, the dose of light may be administered for a period of between 1 second and 1 hour. In some embodiments, the amount of light can be red light (about 700-635 nm), yellow light (about 590-560 nm), or ultraviolet (UV) light, such as UVC light. In some embodiments, body 12 may passively resist bacterial colonization under ambient light, which may be administered to a photosensitizer integrated with body 12 . In some embodiments, the photosensitizer produces more in response to ambient light than the photosensitizer produces in response to an amount of light ranging from 0.5 J/cm ² to 320 J/cm ² . It can produce lower levels of ROS.

In some embodiments, the dose of light can activate the photosensitizer, which enters a first excited singlet state when the excitable electrons are promoted to a higher energy level. can reach. The first excited singlet state can decay to lower energy levels by a process of intersystem crossing to states called triplets. The triplet state can be long-lived, a feature that allows photosensitizers to react with triplet oxygen molecules and other biomolecules. When the triplet state photosensitizer transfers energy to triplet oxygen, a ROS called singlet oxygen can be generated. Both triplet state photosensitizers and singlet oxygen are labile molecules, so they can provide body 12 with decontamination and antimicrobial resistance. In some embodiments, different wavelengths of light may be administered to body 12 at different times, and/or body 12 may be activated in response to different wavelengths of light. May contain sensitizers.

Referring to FIG. 1B, in some embodiments, medical device 10 can include coating 15 that can be disposed on all or a portion of the surface of body 12 . In these embodiments, the photosensitizer may be located within coating 15 . In some embodiments, integrating the photosensitizer with the body 12 of the medical device 10 can include applying a coating 15 to the surface of the medical device 10 . In some embodiments, the concentration of photosensitizer in coating 15 can be between 0.05% and 5%. In some embodiments, the photosensitizer can be dissolved in urethane, polyurethane, or another suitable solvent and cured on body 12 to form coating 15 .

Referring now to FIG. 2, in some embodiments, body 12 of medical device 10 may include catheter adapter 16 and/or catheter 18 extending distally from catheter adapter 16 . In some embodiments, photosensitizers can be integrated with body 12 via one or more of the methods discussed with respect to FIG. Thus, in some embodiments, the photosensitizer is mixed with the base resin, disposed within a coating on the body 12, absorbed into the base resin, or used in another material. can be coextruded with In some embodiments, catheter 18 may be coextruded with a photosensitizer and another material. In some embodiments, catheter 18 may comprise a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. In some embodiments, catheter 18 may include a proximal end 20 secured within catheter adapter 16 and a distal end 22 configured for insertion into a patient's vasculature.

In some embodiments, extension tube 24 may extend from catheter adapter 16 . In some embodiments, the distal end of extension tube 24 may be integrated or coupled to side port 26 of catheter adapter 16 . In some embodiments, the proximal end of extension tube 24 may be integrated or coupled with adapter 28, which may include a Y-adapter or another suitable adapter.

Referring now to FIG. 3 , in some embodiments, medical device 10 can include connector 29 , which can include body 12 . In some embodiments, connector 29 may include a needle-free connector such as, for example, the SMARTSITE® needle-free valve available from Becton, Dickinson & Company of Franklin Lakes, NJ. In some embodiments, connector 29 is coupled to adapter 28 (see, eg, FIG. 2), another adapter coupled to a particular catheter adapter, a port of a particular catheter adapter, or another suitable location. obtain. In some embodiments, photosensitizers can be integrated with body 12 via one or more of the methods discussed with respect to FIG. Thus, in some embodiments, the photosensitizer is mixed with the base resin, disposed within a coating on the body 12, absorbed into the base resin, or used in another material. can be coextruded with

4, in some embodiments, medical device 10 can include surgical mesh 30, which can include body 12. As shown in FIG. In some embodiments, photosensitizers can be integrated with body 12 via one or more of the methods discussed with respect to FIG. Thus, in some embodiments, the photosensitizer is mixed with the base resin, disposed within a coating on the body 12, absorbed into the base resin, or used in another material. can be coextruded with

5A-5B, in some embodiments, medical device 10 is used with a medical device that is inserted into a patient's vasculature via a skin insertion or puncture site, which may include body 12. It may include a dressing 32 for cleaning. In some embodiments, photosensitizers can be integrated with body 12 via one or more of the methods discussed with respect to FIG.

In some embodiments, dressing 32 may be configured for use with a medical device, such as catheter 18, which has a portion of the medical device that pierces and protrudes from the patient's skin (e.g., FIG. 2). ). In some embodiments, the body 12 may include slits 34 configured to allow the body 12 to be placed around a medical device and on the surface of the skin, such that The body of the dressing surrounds and contacts the skin entry or puncture site. In some embodiments, slits 34 may be formed in body 12 by cutting, stamping, or other similar mechanical forming techniques. In some embodiments, the width of slit 34 may be adapted to facilitate placement over a medical device already placed within the patient's vasculature. In some embodiments, slit 34 may allow dressing 32 to completely surround the medical device at the site of skin insertion or puncture.

In some embodiments, body 12 can take on any geometric shape. In some embodiments, body 12 may be disc-shaped. In some embodiments, the shape of body 12 may include oval, triangular, square, rectangular, pentagonal, hexagonal, octagonal, and the like. In some embodiments, body 12 can be made from any physiologically compatible material that can be impregnated or imbibed with a photosensitizer. In some embodiments, body 12 may be constructed from oxidized cellulose foam, collagen fibrils, alginate hydrogel, or another suitable material.

In some embodiments, body 12 may include openings 36 for receipt of medical devices. In some embodiments, slit 34 may extend from opening 36 to perimeter 38 of body 12 . In some embodiments, slit 34 allows body 12 to completely surround and contact an insertion site through which a medical device such as, for example, catheter 18 (see FIG. 2) may pass. can make it possible.

Referring now to FIG. 6, shown is a chamber 40 for providing a dose of light to medical device 10, according to some embodiments. In some embodiments, the chamber 40 can be placed within a cover 42 such as a box, container, or the like. In some embodiments, one or more sides of chamber 40 may include mirrors 44 . In some embodiments, one or more light sources 46 may be positioned within chamber 40 . For example, the light sources include one or more of a first light source 46a, a second light source 46b, and a third light source 46c (which may be referred to as "light sources 46" in this disclosure). obtain.

In some embodiments, each of light sources 46 may emit an amount of light having a particular wavelength of light. In some embodiments, a first light source 46a may emit a first wavelength, a second light source 46b may emit a second wavelength, and a third light source 46c may emit a third wavelength. obtain. For example, a first light source 46a may emit UVC light, a second light source 46b may emit red light, and a third light source 46c may emit yellow light. In some embodiments, light source 46 may include a light emitting diode (LED). In some embodiments, light sources 46 may be activated at different times and/or for different durations. In some embodiments, different photosensitizers integrated with the body 12 can be activated in response to activation of the light source 46 to produce free radicals and medical devices disposed within the chamber 40 . Provides 10 decontamination.

All examples and conditional language recited in this disclosure are intended for educational purposes to help the reader understand the disclosure and the concepts contributed by the inventors to further the art. and should be construed without limitation to such specifically recited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations may be made thereto without departing from the spirit and scope of the disclosure.

Claims (20)

a medical device,
the main body;
a photosensitizer integrated with the body;
A medical device comprising: 2. The medical device according to claim 1, wherein the main body is made of a base resin, and the photosensitizer is mixed with the base resin. 3. The medical device according to claim 2, wherein the base resin contains polyphenylsulfone, polyurethane, or silicone. 3. The medical device of claim 2, wherein the concentration of said photosensitizer in said base resin is between 0.05% and 5%. 2. The medical device of claim 1, further comprising a coating disposed on said body, said photosensitizer disposed within said coating. 6. The medical device of claim 5, wherein the concentration of said photosensitizer in said coating is between 0.05% and 5%. 2. The medical device of claim 1, wherein said medical device includes a catheter adapter and a catheter extending distally from said catheter adapter. 8. The medical device of claim 7, wherein said catheter is coextruded with said photosensitizer and other materials. 8. The medical device of Claim 7, wherein the medical device comprises a needleless connector or cap. 2. The medical device according to claim 1, wherein said main body is formed of a base resin, and said photosensitizer is absorbed into said base resin. 10. The medical device according to claim 9, wherein the base resin contains polyphenylsulfone, polyurethane, or silicone. 2. The medical device of claim 1, wherein the photosensitizer comprises methylene blue, new methylene blue, nile blue, rose bengal, toluidine blue O, or crystal violet. 3. The medical device of claim 1, wherein said medical device comprises an ultrasound transducer. 11. The medical device of claim 1, wherein said medical device comprises a dressing. A method of disinfecting a medical device, said method comprising:
providing the medical device, the medical device comprising a body and a photosensitizer integrated with the body;
administering a light dose ranging from 0.5 J/cm ² to 320 J/cm ² to the photosensitizer integrated with the main body of the medical device for 1 second to 1 hour;
A method comprising: 16. The method of claim 15, further comprising integrating the photosensitizer with the body of the medical device. 17. The method of claim 16, wherein the body is formed of a base resin, and integrating the photosensitizer with the body of the medical device comprises: A method comprising mixing with a resin. 17. The method of claim 16, wherein integrating the photosensitizer with the body of the medical device comprises coating a surface of the body, wherein the photosensitizer comprises the disposed within a coating. 17. The method of claim 16, wherein the medical device includes a catheter adapter and a catheter extending distally from the catheter adapter, and integrating the photosensitizer with the body of the medical device. comprises co-extruding said catheter with said photosensitizer and other materials. 17. The method of claim 16, wherein the medical device comprises a base resin, and wherein integrating the photosensitizer with the body of the medical device comprises adding the photosensitizer to the base resin. a method comprising imbibing the

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